Trial Profile
A Phase 3, Double-blind, Placebo-controlled, Randomized Discontinuation Study Followed by Open-label Extension Evaluating Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 17 Oct 2023
Price :
$35
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At a glance
- Drugs Amifampridine (Primary)
- Indications Lambert-Eaton myasthenic syndrome
- Focus Registrational; Therapeutic Use
- Sponsors BioMarin Pharmaceutical; Catalyst Pharmaceuticals
- 13 Oct 2023 According to a Catalyst Pharmaceuticals media release,Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS
- 09 Dec 2018 Canada, Czech Republic, and Italy were the planned locations.
- 28 Nov 2018 According to a U.S. Food and Drug Administration media release, US FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.